Class III · Low risk Terminated
Phytonadione Tablets 5mg
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
FDA Drug Recalls
14,801 recalls, newest first
Class III · Low risk Terminated
Mephyton
Reason Failed Impurities/Degradation Specifications:Out of specification during the 24 month stability testing of Impurity D.
Class II · Moderate risk Terminated
Nitrofurantoin Capsules USP
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Sulfur Ointment 10%
Reason Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly placed on product.
Class II · Moderate risk Terminated
Chlorhexidine Gluconate Oral Rinse USP 0.12%
Reason cGMP deviations: The firm was notified of the manufacturer's expanded recall.
Class II · Moderate risk Terminated
Acetaminophen Injection 1
Reason Discoloration and failed pH specifications
Class II · Moderate risk Terminated
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Reason Labeling: Missing instructions for use insert
Class II · Moderate risk Terminated
Levetiracetam Oral Solution
Reason Defective container: Customer complaints for oral solution leaking from bottles.
Class I · High risk Terminated
Ketorolac Tromethamine Injection
Reason Presence of Particulate Matter - found in reserve sample vials at the firm.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class II · Moderate risk Terminated
IMC Wash-Free Hand Sanitizer
Reason CGMP Deviations: product manufactured at the same facility that produced product that FDA sampled and found to be subpotent for ethanol and contained methanol.
Class III · Low risk Terminated
Oxycodone Hydrochloride Oral Solution
Reason Presence of Foreign Substance: Particulate matter was found in multiple lots of product.
Class III · Low risk Terminated
Epinephrine/Lidocaine HCl
Reason Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk Terminated
NDC 64380-721-06 Tacrolimus Capsules
Reason Failed Moisture Limits
Class II · Moderate risk Terminated
Zerbaxa
Reason Lack of assurance of sterility: The results of sterility tests of seven batches of product were out of specification. Five of these batches tested positive for Ralstonia pickettii and two batches produced turbid results that could not be further identified. While all product distributed to the market has met the registered specifications for release, including for sterility, it was manufactured on the same equipment as the affected batches.
Class III · Low risk Terminated
Benzhydrocodone and Acetaminophen Tablets
Reason Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
Class II · Moderate risk Terminated
Ketamine 50 mg/5mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 5000 mg/50 mL in Sodium Chloride 0.9%
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
HYDROmorphone HCl 10mg/50mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
fentaNYL 100 mcg/2mL Injection for IV or IM Use
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
ePHEDrine 25 mg/5 mL in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
SUCcinylcholine Chloride 100 mg/5mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
Rocuronium Br 50 mg/5mL
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit
Class II · Moderate risk Terminated
PHENYLephrine HCl 500 mcg/5mL in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit